Measuring Total Energy Expenditure in Critically Ill Patients Using the Doubly Labelled Water Method

NCT07256340 | Recruiting

• 1 other identifier: 2025/108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill patients, such as those with trauma or sepsis, experience high rates of malnutrition (up to 75%). Malnutrition worsens outcomes by increasing infection rates, hospital stays, mortality, and healthcare costs. Adequate nutrition is therefore crucial in the ICU. To ensure appropriate nutrition, accurate determination of total energy expenditure (TEE) is essential. In practice, predictive equations are often used, but these can misestimate TEE in ICU patients due to complex metabolic changes. Indirect calorimetry is recommended but limited by technical constraints. Consequently, the doubly labeled water (DLW) method, though expensive, offers a precise and non-invasive way to measure TEE over time. This study applies the DLW method in ICU patients to improve energy assessment and guide personalized nutrition strategies that support recovery and outcomes.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Energy expenditure

  Measured using the DLW method by only taking urine samples

  Min: 1-5 days; Max: 1-20 days

Study Arms (1)

DLW-based energy assessment

EXPERIMENTAL

Single-arm observational study

Diagnostic Test: DLW-based energy assessment

Interventions

DLW-based energy assessment DIAGNOSTIC_TEST

Measuring TEE in IC patients with DLW

DLW-based energy assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the ICU of Jessa Hospital
• Male and female sexes
• Age: \> 18 years old
• Expected ICU stay of 5 days or more

You may not qualify if:

• Dialysis

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michèlle Hendriks

CONTACT

+31 43 388 1184; michelle.hendriks@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective, interventional trial with a single group design.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)